Identifying candidates for immunotherapy with cemiplimab to treat advanced cutaneous squamous cell carcinoma: an expert opinion.

Cutaneous squamous cell carcinoma (CSCC) is the second most common skin malignancy in white-skinned populations. Only a minority of patients (<5%) develop advanced disease, but this is often difficult to treat and characterised by a poor prognosis. Cemiplimab, a fully human IgG4 monoclonal antibody against programmed cell death-1 receptor, is indicated for advanced (i.e. locally advanced or metastatic) CSCC. Although the definition of metastatic CSCC is clear, there is currently no agreed definition of locally advanced CSCC. In recent guidelines, locally advanced CSCC was described as non-metastatic CSCC that is unlikely to be cured with surgery, radiotherapy or combination treatment. A multi-disciplinary advisory group of Italian CSCC experts was convened to develop criteria to assist in identifying appropriate candidates for cemiplimab therapy in advanced CSCC, based on the literature and clinical experience. In locally advanced CSCC, absolute, or mandatory, criteria for the use of cemiplimab are deep invasion, multiple lesions without defined margins, inadequate surgical excision margins and multiple recurrences, whereas relative criteria include large lesions, in critical or functionally significant areas and that are surgically complex. In addition, physicians should consider patient willingness/preferences (an absolute criterion), and their age and health status/comorbidities (relative criteria). It is hoped that these proposed absolute and relative criteria will help guide rational identification of patients who will receive maximum benefit from immunotherapy, while more clinical data accumulate.

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© The Author(s), 2022.

Déclaration de conflit d'intérêts

Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Giuseppe Argenziano, Maria Concetta Fargnoli, Fabrizio Fantini, Massimo Gattoni, Giulio Gualdi, Giovanni Pellacani, Pietro Quaglino, Paola Queirolo and Teresa Troiani received a fee for their attendance and contribution to the advisory board meetings. Giuseppe Argenziano has no conflict of interest. Maria Concetta Fargnoli has served on advisory boards and received honoraria for lectures and research grants from Mylan, Medac Pharma, Pierre Fabre, Sanofi-Genzyme, Sunpharma and Merck Sharp & Dohme (MSD). Fabrizio Fantini, Massimo Gattoni, Giulio Gualdi and Francesco Pastore have no conflicts of interest. Pietro Quaglino has received speaker fees and contributed to advisory boards for Sanofi, Sun-Pharma, Roche, Igea, BMS, Novartis, MSD and Pierre Fabre. Paola Queirolo has received speaker fees and contributed to advisory boards for Roche, Novartis, BMS, MSD, Merck, Sanofi, SunPharma and Pierre Fabre. Teresa Troiani has served on advisory boards from Novartis, BMS Roche, Servier and Amgen Bayer.